Apparatus and methods for tissue closure

ABSTRACT

Apparatus and methods are provided for treating a tissue opening, for example a trocar opening used in a minimally invasive surgical procedure. In a tissue closure device, a finger guard or shield can be used, handle or holding area or areas can be used, and positioning indicators can be used. A resiliently flexible target material can also be used for reliably holding a suture during the procedure. The resiliently flexible target material may be included as part of a removable mating component for use with a movable wing. Introducers can be used having a suture holder, an alignment indicator and insertion limits.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a National Stage of International patent applicationPCT/US2013/020094, filed on Jan. 3, 2013, which claims priority to U.S.provisional patent application No. 61/583,172, filed on Jan. 4, 2012,the disclosures of which are incorporated by reference in theirentirety.

BACKGROUND

Field

This relates to tissue closure devices, including surgical suturingdevices as well as such devices that can be used for intra-abdominalsuturing and suturing of puncture wounds generated by surgical trocarsand other puncturing devices.

Related Art

Minimally invasive methods for conducting surgery on internal organs,tissues, ligaments and bones use extremely small instruments such ascatheters, laparoscopes, and the like. The instruments are introducedusing very small incisions, for example on the order of five to 18 mm indiameter, into which a trocar or other introducing device is placed. Thetrocars may have a diameter, for example, between 3 mm and 30 mm, withthe smaller trocars leaving the opening substantially unchanged. Thelarger trocars may enlarge the opening. The trocars provide a reliableand fixed opening for introducing and removing various surgicalinstruments, viewing devices and other instruments used during thesurgical procedure.

While the incisions and the trocar opening are quite small bytraditional surgical standards, they still require closure aftercompleting the surgical procedure. Surgical closure reduces thepossibility of post-surgical infection, post-surgical herniation (forexample in abdominal surgeries), subsequent bleeding or other effects.Closure can be accomplished either through manual suturing or suturinginstruments used to complete the closure. In either case, suturing ismade difficult by the small opening size, for example not only formanipulating the suture but also for visualizing the procedure. Closureis also made more difficult by the need to suture the subcutaneoustissue, for example fascial layers, separate from closure of theoverlying skin, and doing so through a very small opening in the skin.

Conventional closure techniques such as those for closing openings inthe abdominal wall pass sutures through the abdominal wall tissue adistance from the original trocar incision. One or more sutures are thentied off to close the subcutaneous layer followed by suitable closure ofthe skin layer. It has been noted that the distance of the suturelocation from the original incision opening is important in order tosecure a suitable amount of abdominal wall tissue for forming a reliableclosure. If the distance is too small, the closure may not be enough toreliably close the opening without later complications. See, forexample, US Patent Publication 20060030868, incorporated herein byreference.

Tissue closure devices, for example laparoscopic port closure devices,may be introduced into the opening after removal of the trocar device tomake easier the suturing of the trocar opening. Various methods andstructures may help in closing the opening, but may require asignificant number of steps for completing the closure. Some devices mayrequire a significant amount of manual care in suturing the opening andtying off the suture, as well as close visualization for accomplishingthe closure. Additionally, some devices have a significant number ofcomponents or special devices in order to accomplish the closure, orthey may not provide consistent and reliable results even under normaloperating circumstances.

SUMMARY

Apparatus and methods are provided that are easy to use for closing atissue opening, for example a trocar opening used in a minimallyinvasive surgical procedure. One or more of the examples of theapparatus and methods described are easy to use and provide a reducednumber of steps to produce a consistent and reliable closure. Theapparatus and methods may be more simple than conventional techniques,and can be possibly done without scope visualization or without the aidof insufflation of the abdominal cavity (e.g. pneumoperitoneum) underappropriate circumstances. One or more of these features can be providedwith the apparatus and methods described herein.

In one example of apparatus and methods for closing a tissue opening,for example an abdominal trocar opening used in surgery, a closuredevice is used for closing the tissue opening. A passageway in theclosure device, which in one example may be a trans-lateral passageway,is used to guide a needle or other suture carrier along the passagewayand through a tissue layer to be closed. A surface or barrier formed onthe closure device distal of an opening to the passageway helps toprotect an operator's finger while a suture is being introduced to thepassageway in the body. The surface or barrier may be a shield, disc,plate guard or other blocking element that can reduce the possibility ofneedle stick when an operator's finger or fingers are placed under thesurface and the introducer is introduced into the opening from theproximal side of the surface. Where the closure device has a singlesuture introducing opening, the surface can surround the opening withsufficient coverage over the operator's fingers without fully encirclingthe closure device. Where the closure device has two or moresuture-introducing openings, respective surfaces can surround theopenings, or a single surface can surround all openings and extendcompletely around the body. In an example where the closure device hasan even number of suture-introducing openings, the openings may bearranged in pairs, for example on diametrically opposite sides of thebody. For such openings, the surface can conveniently extend completelyaround the body.

In one example of a closure device having a needle-introducing opening,the body of the device may include finger grasping areas foraccommodating an operator's fingers. The grasping areas may includesurfaces complementary to finger curvature, and may include surfacevariations for helping the operator to grasp the body of the closuredevice. The surface variations may be ridges, grooves, knurling,dimples, surface texture variations or other surface variations to helpthe operator reliably grasp the body of the closure device.

In another example of apparatus and methods for closing a tissueopening, for example a trocar opening, a closure device with apassageway for receiving a suture-carrying needle or other closuredevice includes a surface or other construction adjacent the opening forshielding an operator's fingers from needle sticks. The closure devicemay also include a slot or other longitudinally extending openingextending from a surface of the body to the passageway. The slot allowsthe suture to be disengaged from the body of the closure device afterthe needle or other closure device has carried the suture along thepassageway and through a tissue layer. The suture can be disengaged fromthe passageway while the closure device is still positioned in thetrocar opening or during or after the closure device is removed from thetrocar opening. In a closure device having a shield for an operator'sfingers, the slot may also extend into the shield, thereby permittingseparation of the suture from the passageway over the entire length ofthe passageway. In one example, the slot extends longitudinally of theclosure device body, and may also extend partially about a perimeter ofthe body. Where the closure device includes a plurality ofsuture-introducing passageways, a respective number of slots, eachcorresponding to a passageway, permit separation of the suture from theclosure device completely from above the shield to below the shield.

In a further example of a closure device for closing a tissue opening,for example a trocar opening, the closure device includes alongitudinally extending body having a proximal portion and a distalportion. The distal portion of the closure device body includes one ormore projections extending at least partly laterally of the body andhaving a suture-receiving target material. The target material isresiliently flexible and initially has an unperforated proximal surface.The target surface is also configured to be capable of being puncturedby a needle or other device suitable for carrying a suture multipletimes in a given patient in a surgical setting. In one example, thetarget surface material is selected so as to reliably hold a length ofsuture using friction between the outer wall of the suture material andtarget surface material, for example a size 0 suture, under normaloperating conditions. A suitable target surface material includessilicone rubber, but may include but be not limited to other commonlyavailable biocompatible thermoset or thermoplastic materials (e.g.Polyurethane, polyethylene, C-flex, and the like) that may consist of asingle or compounded materials, suitable to provide the desired frictionforce to hold and retain the commonly used surgical suture materials.The target material may consist of a single layer material or may be ofseveral layers, each layer having different characteristics orproperties designed to achieve the friction necessary to hold the suturein place but at the same time flexible enough to allow any needle orother suture carrying device to penetrate. With the describedconfiguration, specially-configured target materials are not required.

In an additional example of a closure device for closing a tissueopening, for example a trocar opening, the device includes alongitudinally extending body. The body includes a proximal portion anda distal portion, the proximal portion being used for manipulating theclosure device and the distal portion for extending within the trocaropening and for making easier the placement and retrieval of one or moresutures. The body further includes one or more indicators or markingsfor visibly indicating proper location or positioning of the closuredevice for optimal operation. For example, a visible marking can be usedto indicate maximum tissue depth, or maximum depth of the closure deviceinto the tissue. In another example, or in addition, a visible markingcan be used as visual warning to the operator that the patient's softtissue bed may be too insubstantial in terms of thickness and, if theindicator is at or near the skin layer upper surface, that the needlewill exit at a point above the skin level instead of below it asdesired. In another example, or in addition to one or more of the othermarkers, a visible marking can be used to indicate desired closuredevice positioning within a trocar opening relative to a tissue layer tobegin or transition the closure device to another configuration. Forexample, the tissue layer may be the peritoneum, and the visible markingmay be used to indicate that a target element for a suture is positionedfor deployment. In another example, the visible marking may be used as avisual warning to the operator that the patient's soft tissue bed may betoo insubstantial in terms of thickness and, if the indicator is at ornear the skin layer upper surface, that the needle will exit at a pointabove the skin level instead of below it as desired. In a furtherexample, a visible marking may be used to indicate when the closuredevice has been positioned within the tissue opening, for examplerelative to a peritoneum layer, to permit the easiest retrieval of asuture that may be held at that time on a part of the closure device.

In a further example of a closure device for closing a tissue opening,for example a trocar opening, the device includes a longitudinallyextending body having a proximal portion and a distal portion. Thedistal portion includes a suture holding portion extending a firstdistance laterally from a first axial position on the body. The bodyfurther includes a substantially straight, suture-receiving passagewayextending at an angle to a central axis of a body. The passagewayincludes an entrance opening and an exit opening on the body distal ofthe entrance opening and it is substantially aligned with the sutureholding portion. The exit opening on the body is positioned proximallyat a second axial position relative to the first axial position andspaced therefrom a second distance. The angle of the passageway, thesecond distance and the first distance are chosen so that a ratio of thesecond distance to the first distance is no more than preferablyapproximately 2.5:1. For example, if the suture holding portion isspaced from the body approximately 1 cm, the distance from the firstaxial position on the body to the exit opening is no more thanapproximately 2.5 cm. The ratio can be less than 2.5:1, but in oneexample, the first distance between the first axial position on the bodyand the suture holding portion is at least 1 cm. Additionally, if thefirst distance between the first axial position on the body and thesuture holding portion is at least 1 cm, the ratio can be less than2.5:1, for example by adjusting the second distance or by adjusting theangle of the passageway, or both.

Examples of accessories and their use with closure devices for tissueopenings, needles or suture introducers can include one or more featuresfor making their use easier with closure devices. One feature mayinclude a combination of needle length and handle configured such thatwhen the needle is fully introduced into the closure device, the handleor other structure on the needle contacts a structure on the closuredevice substantially preventing further introduction of the needle intothe closure device, and therefore substantially preventing furtheringress of the needle into a tissue layer. Such a configuration reducesthe possibility of unintended needle stick of a tissue layer, organ orother nearby surface. Additionally, such a configuration in combinationwith an appropriately-designed closure device for known patientanatomies allows an operator to more confidently follow the closuresteps in less time and with fewer redundant steps. Alternatively, avisual marking or position indicia provided in the needle structure mayalso be used as a means to indicate the depth of the needle duringsuture introduction.

In another feature for an accessory and its use, such as that for aneedle or suture introducer, the needle may include a distal point and asuture-retention structure proximal of the needle point. The retentionstructure may include a groove or undercut having an entrance openingwhere the entrance opening is sized larger than the suture and allowsloading of the suture into the groove or undercut. The groove orundercut is sized such that the narrowest opening includes a maximumspacing slightly less than the suture diameter to be used with theneedle. The maximum spacing is selected so as to reliably hold thesuture within the groove when the suture is in a relaxed configuration,and for example under the weight of gravity. However, for a greaterforce such as might be applied manually, the suture can be removed fromthe groove and out the opening. Such a greater force would be greaterthan the force of gravity on the suture hanging from the groove. In thepresent applications for a needle in use with a closure device, thegroove opens distally and has a groove bottom proximal of the opening.

A further feature for an accessory and its use, such as that for aneedle or suture introducer having a groove for releasably retaining asuture, the groove is formed in a side of the needle proximal of adistal needle tip. The needle includes an indicator on a side surface ofthe needle at a proximal portion of the needle, and the indicator ispositioned perimetrically with respect to the needle at about the sameposition as the groove is located. The indicator can be a raised,longitudinally-extending the ridge or land, an arrow, grooves, uniquefinger holdings or other configurations indicating the groove position.The operator can use the indicator to establish in which radialdirection the groove entrance opening is facing when the needle tip isnot easily visualized, such as when it has passed through or beyond atissue layer. This feature is also beneficial to the operator orsurgical team when manually loading the suture into the needle groove inan operating room or suite where the lighting has been dimmed or isabsent.

Accessories for use with closure devices for tissue openings canincorporate any one or more of the features described herein withrespect to a needle or suture introducer. The needle may also include ahandle having finger grip surfaces or other manual assist configurationsfor helping the operator manipulate the needle.

The apparatus described herein, as well as other apparatus, can be usedin accordance with one or more methods for closing tissue openings. Inthe context of using one or more methods with a closure device describedherein, such as may be used for closure of abdominal trocar openings,the closure device can be inserted into a trocar opening after thetrocar has been removed. In one example, the closure device can beinserted until the skin surface comes adjacent a proximal indicator, forexample a circumferential line about the closure body. Additionally,where scope-based visualization is available, clearance of a distalindicator interior to the peritoneum indicates that the target wings orother target elements can be deployed laterally of the closure body.Alternatively, where scope-based visualization is not used or available,the skin surface adjacent the proximal indicator will indicate that thetarget wings or other target elements can be deployed laterally for mostpatients. Sutures can then be introduced and closure effected asdesired.

The apparatus described herein, as well as other apparatus, can be usedin accordance with another example of a method for closing tissueopenings. Regardless of whether or not the foregoing method ofpositioning a closure device is used, sutures can be introduced intotissue layers through a closure device using a suture-carryingintroducer, for example a needle. The needle can be loaded with a suturemanually or automatically by moving a suture portion along the shaft ofa needle toward a groove opening at a distal portion of the needle. Thesuture portion is moved along the shaft proximal to distal or distal toproximal until the suture portion enters the groove opening, for exampleradially inward from the shaft outer surface, after which the sutureportion is moved proximally of the needle tip. The operator mayappreciate a tactile sensation when the suture enters the groove openingand also observe it visually depending upon the lighting in theoperating room. A slight force is applied to the suture portion toovercome a restriction in the groove opening having a dimension slightlyless than an outer dimension of the suture, after which the suturepasses the restriction and reaches the bottom of the groove, for exampleat the proximal-most portion of the groove. The retention of the sutureportion in the groove can be tested if desired by directing the needlepoint downward with the suture also extending downward by gravity. Thespacing of the restriction in the groove opening is such that the sutureremains within the groove as the force necessary to move the sutureportion past the groove restriction is greater than the force of gravityon the suture.

The suture can then be introduced, as well as other sutures, into thetissue and closure effected as desired.

In additional examples, apparatus such as that described herein as wellas other apparatus can be used in accordance with a further example of amethod for closing tissue openings. Whether or not any other methodsherein of positioning a closure device or loading a suture-carryingintroducer are used, a closure device inserted into a trocar opening canbe loaded with one or more sutures without requiring the operator tointervene to manually or with additional tools detach a suture from anintroducer and attach the suture to the closure device. In one example,the closure device is inserted into the trocar opening with a relativelyhigh friction target material on a distal portion of the closure device,for example below the peritoneum. The target material is high frictionrelative to the suture material to be used with the closure device.Additionally in one example, the target material is un-perforated priorto initial use and presents a uniform, un-breached surface facingproximally for receiving the suture. The target material is alsoresiliently flexible, and when a suture introducer, for example asuture-carrying needle, breaches the proximal-facing surface and embedsthe suture in the target material, the friction generated in the targetmaterial grasps and holds the suture even as the introducer iswithdrawn. One exemplary introducer may have a reduced-opening groovefor loosely holding a suture portion that can be removed by withdrawingthe introducer from the target material. Other sutures may be introducedand closure effected as desired.

In another example of a method for closing a tissue opening, a closuredevice may be preloaded with one or more sutures and introduced into atissue opening, for example a trocar opening. When the closure device issuitably inserted, one or more respective wings or suture-holdingelements may be deployed substantially laterally of a closure devicebody. In one example, a suture is releasably positioned and held atleast 1 cm laterally away from the closure device body. In anotherexample, a suture may be held in a resiliently flexible material, forexample embedded in silicone rubber or other suitable bio-compatiblematerial that provides the desired friction properties in conjunctionwith the suture. The tissue layer overlying the suture is then piercedwith a retriever element, the suture retrieved and then pulled throughthe tissue layers to a position outside the patient. Similar steps canbe followed for retrieving any additional sutures, and then closurecompleted as desired. Other closure device configurations are alsopossible for use in this procedure, for example one in which one or moresutures are held by physical restrictions or interference fits betweenthe suture and the suture holder (for example on a wing or othersuture-holding element). Additionally, the closure device can include aguide channel or other retriever guide defining the path for theretriever necessary to substantially guarantee contact between thedistal tip of the retriever and the target suture, for example evenwithout visualization. Such a guide may be a channel, such as oneextending along a line intersecting the target suture position, or atrans-lateral channel extending from one side of the closure device bodyto the other side and then intersecting the target suture position. Aplurality of such guides may be included, for example for respectivesuture positions.

In a further example of a method for closing a tissue opening, a closuredevice, including any of those described herein, may be introduced intoa tissue opening, for example after removal of a trocar. If the closuredevice has been properly introduced into the opening, for example asindicated by a proximal indicator being adjacent a skin surface or asindicated by visualization of a distal indicator being inferior to thetissue layer to be closed (for example a peritoneum and abdominalfascia), one or more wings or other suture target elements can bedeployed laterally of the closure device body. The target or targetelements may be deployed preferably at least 1 cm from the closuredevice body (measured perpendicular to the body). They are deployed bymanipulating an actuator rod relative to the closure device body, suchas through manipulator rings or other grasping elements. In one example,the target elements may be locked in an insertion position (un-deployed)until unlocked. Once deployed, the target elements can also be locked inthe deployed configuration, for example through re-engagement of alocking element. When the closure device is positioned and configured asdesired, the operator can grasp the body of the closure device at a bodyposition distal of suture openings. While grasping the body, a suturecarrying introducer is inserted into an opening and guided throughtissue to be closed and into a respective target element. In oneexample, the guide is a trans-lateral passageway with an entranceopening above the operator's grasp on the closure device body and anexit along a line substantially intersecting the suture target. Aclosure device may be used that has a guard or shield between theoperator's grasp on the closure device body and the suture openings.

In the method described in the foregoing paragraph, the suture may beintroduced using an introducer with a stop or other element on theintroducer that engages a corresponding surface on the closure devicethat prevents further ingress of the introducer through the tissue andthrough the target. The introducer may include grasping surfaces and/oralignment indicators for assisting the operator in properly positioningthe suture in the target element. The introducer can be removed leavingthe suture in the target element, for example embedded in a relativelyhigh friction, resiliently flexible material, for example siliconerubber, and other sutures introduced in a similar manner, if desired.When the desired number of sutures have been embedded in theirrespective targets, a lock or latch is released and the suture targetsreturned to their insertion configuration using the manipulator rings orother grasping elements. The closure device can then be withdrawn fromthe tissue opening carrying with it the suture or sutures previouslypassed through the desired tissue layer. The tissue layers may then beclosed by securing the sutures, and the overlying skin layer may also beclosed. In all methods and devices described herein, it is understoodthat the devices and steps taken to achieve the desired result can berepeated for subsequent closures on the same patient as required.

These and other examples are set forth more fully below in conjunctionwith drawings, a brief description of which follows.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an upper left front isometric view of a tissue closure deviceaccording to one example and a suture introducer according to oneexample inserted into a guide of the closure device.

FIG. 2 is a left side elevation view of the assembly shown in FIG. 1including a partial schematic of a tissue layer into an opening in whichthe closure device may be inserted.

FIG. 3 is a right side elevation view of the assembly of FIG. 1.

FIG. 4 is a lower right rear isometric view of the assembly of FIG. 1.

FIG. 5 is a bottom plan view of the assembly of FIG. 1.

FIG. 6 is a front elevation view of the closure device of FIG. 1.

FIG. 7 is a left side elevation view of the closure device of FIG. 1.

FIG. 8 is a bottom plan view of the closure device of FIG. 1.

FIG. 9 is a top plan view of the closure device of FIG. 1.

FIG. 10 is a longitudinal cross-section view of the closure device takenalong 10-10 of FIG. 9.

FIG. 11 is a longitudinal cross-sectional view of the closure devicetaken along line 11-11 of FIG. 9.

FIG. 12 is a left side elevation view of the closure device of FIG. 1 inan insertion configuration.

FIG. 13 is an upper isometric view of a slide unit having finger ringsfor changing the configuration of the closure device of FIG. 1.

FIG. 14 is a top plan view of the slide unit of FIG. 13.

FIG. 15 is a front elevation view of the body of the closure device ofFIG. 1.

FIG. 16 is a side elevation view of the body of the closure device ofFIG. 1.

FIG. 17 is a top plan view of the body of the closure device of FIG. 1.

FIG. 18 is a bottom plan view of the closure device of FIG. 1.

FIGS. 19-23 are transverse cross-sectional views of the closure devicebody taken along the respective lines in FIG. 16.

FIG. 24 is an upper isometric view of a suture target wing for theclosure device of FIG. 1.

FIG. 25 is a bottom plan view of the suture target wing of FIG. 24.

FIG. 26 is a side elevation view of the suture target wing of FIG. 24.

FIG. 27 is a rear elevation view of a suture target wing of FIG. 24.

FIG. 27A is a longitudinal cross section of the target wing of FIG. 27taken along line 27A-27A.

FIG. 28 is a lower front isometric view of the suture target wing ofFIG. 24.

FIG. 29 is a front isometric view of a needle assembly from the assemblyof FIG. 1.

FIG. 30 is a front plan view of the needle assembly of FIG. 29.

FIG. 31 is a detailed view of the tip of the needle assembly of FIG. 29taken at 31-31.

FIG. 32 is an isometric view of another example of a needle assemblythat can be used with any of the closure devices described herein.

FIG. 33 is a side elevation view of the needle assembly of FIG. 32.

FIGS. 33A-33C our detailed views of a distal portion of the needleassembly of FIGS. 32-33.

FIG. 34 is a side elevation view of the needle assembly of FIG. 32.

FIG. 35 is another example of a tissue closure device for use with anyof the needle assemblies and for any of the procedures described herein.

FIG. 36 is an upper isometric view of a further example of a tissueclosure device for use with any of the needle assemblies and for any ofthe procedures described herein.

FIG. 37 is a side elevation view of the tissue closure device of FIG.36.

FIG. 37A is a transverse cross-section of the tissue closure device ofFIG. 36 taken along line 37A-37A of FIG. 37.

FIG. 37B is a transverse cross-section of the tissue closure device ofFIG. 36 taken along line 37B-37B of FIG. 37.

FIG. 37C is a transverse cross-section of the tissue closure device ofFIG. 36 taken along line 37C-37C of FIG. 37.

FIG. 38 is a top plan view of the tissue closure device of FIG. 36.

FIG. 39 is another side elevation view of the tissue closure device ofFIG. 36.

FIG. 40 is a side isometric and exploded view of a suture-receiving wingfor use with a tissue closure device, including any of the tissueclosure devices described herein.

FIG. 41 is a bottom plan view of the components of FIG. 40.

FIG. 42 is a bottom plan and exploded view of a suture-receiving wingaccording to another example.

FIG. 43 is a side elevation view of assembly of FIG. 42.

FIG. 44 is a right-side elevation of the assembly of FIG. 42.

FIG. 45 is a left upper side isometric view of another example of asuture-receiving wing assembly.

FIG. 46 is an upper right isometric view of the assembly of FIG. 45.

FIG. 47 is a lower right isometric view of the assembly of FIG. 45.

FIG. 48 is an upper right isometric and exploded view of another exampleof a suture-receiving wing assembly.

FIG. 49 is a bottom plan view of the assembly of FIG. 48.

FIG. 50 is a rear elevation view of the assembly of FIG. 48.

FIG. 51 is a side elevation view of wing assembly in accordance withanother example described herein.

FIG. 52 is a top plan and exploded view of an example of the wingassembly of FIG. 51.

FIG. 53 is a side elevation and exploded view of the assembly of FIGS.52.

FIG. 54 is an isometric and exploded side view of another example of thewing assembly of FIG. 51.

FIG. 55 is a top plan and exploded view of another example of a wingassembly of FIG. 51.

FIG. 56 is a side elevation, partial cutaway and exploded view of theassembly of FIG. 55.

FIG. 57 is a top plan and exploded view of another example of a wingassembly of FIG. 51.

FIG. 58 is a side elevation and exploded view of the assembly of FIG.57.

DETAILED DESCRIPTION

This specification taken in conjunction with the drawings sets forthexamples of apparatus and methods incorporating one or more aspects ofthe present inventions in such a manner that any person skilled in theart can make and use the inventions. The examples provide the best modescontemplated for carrying out the inventions, although it should beunderstood that various modifications can be accomplished within theparameters of the present inventions.

Examples of closure devices and of methods of making and using theclosure devices are described. Depending on what feature or features areincorporated in a given structure or a given method, benefits can beachieved in the structure or the method. For example, closure devicesusing a finger shield or guard may be easier and safer to use. Closuredevices having finger grasping surfaces with selected configurations mayalso help in holding and using the closure device. Closure deviceshaving visual indicator marks also make such closure devices easier andmore reliable to use. Moreover, closure devices having predeterminedsuture delivery configurations may also provide more reliable andconsistent bites of appropriate tissue layers desirable for suturingthese layers than conventional techniques.

Improvements are also provided to components with which the closuredevices may be used. For example, needles or other suture introducersmay make it easier to use the closure device where the needle hasimproved suture holding and release characteristics. They may also beeasier to use with needle insertion indicators or stops for reducing thepossibility of excessive needle insertion. Indicators on the needles mayalso be used with suture holding grooves in the needle tip to indicatethe relative orientation of the suture holding groove when such groovesare not directly visible to the operator.

These and other benefits will become more apparent with consideration ofthe description of the examples herein. However, it should be understoodthat not all of the benefits or features discussed with respect to aparticular example must be incorporated into a closure device, componentor method in order to achieve one or more benefits contemplated by theseexamples. Additionally, it should be understood that features of theexamples can be incorporated into a closure device, component or methodto achieve some measure of a given benefit even though the benefit maynot be optimal compared to other possible configurations. For example,one or more benefits may not be optimized for a given configuration inorder to achieve cost reductions, efficiencies or for other reasonsknown to the person settling on a particular product configuration ormethod.

Examples of a number of closure device configurations and of methods ofmaking and using the closure devices are described herein, and some haveparticular benefits in being used together. However, even though theseapparatus and methods are considered together at this point, there is norequirement that they be combined, used together, or that one componentor method be used with any other component or method, or combination.Additionally, it will be understood that a given component or methodcould be combined with other structures or methods not expresslydiscussed herein while still achieving desirable results.

Closure devices for trocar openings are used as examples of a closuredevice that can incorporate one or more of the features and derive someof the benefits described herein, and in particular closure devices forabdominal tissue openings. Closure of trocar openings in abdominal wallspresent particular issues for acceptable results, and closure devicesfor abdominal openings will be considered in more detail. However,closure devices other than for abdominal wound closures can benefit fromone or more of the present inventions.

It should be understood that terminology used for orientation, such asfront, rear, side, left and right, upper and lower, and the like, areused herein merely for ease of understanding and reference, and are notused as exclusive terms for the structures being described andillustrated.

In accordance with one example of apparatus that can be used for closinga tissue opening, for example a trocar opening in the abdominal wall,and where the apparatus reflects one or more methods that can be usedfor tissue closure, a closure device and needle assembly 100 (FIGS. 1-5)includes a closure assembly or closure device 102 and a needle assembly104. The closure device 102 can be used with the needle assembly 104 asdiscussed herein, or with other suture introducers or needles, and theneedle assembly 104 as discussed herein can be used with other closuredevices. However, for purposes of some of the examples, the closuredevice 102 and the needle assembly 104 will be considered as being usedtogether. Additionally, the present discussion for the application ofthe closure assembly will be in the context of closure of an abdominalopening, but it should be understood that other tissue closures can becarried out with one or more of the components of the assembly.

In the context of a trocar opening 106 (FIG. 2) in an abdominal wall108, the opening 106 extends through a skin and superficial layer 110that may include muscle, depending on the location in the abdomen atwhich the opening is made. The skin and superficial layer 110 will bereferred to as the skin layer 110 for simplicity. Underlying the skinlayer 110 is a fascial layer 112 having a thin peritoneum 114 (notseparately shown for simplicity). The peritoneum forms the lining of theabdominal cavity outside the internal organs (not shown), and it isthrough the skin layer 110, fascial layer 112 and peritoneum 114 thatthe trocar opening and trocar permit access for an operator to theinternal organs. Once the surgery is complete, the trocar opening isclosed by closing the fascial layer 112 and peritoneal layer 114, whiletaking care to avoid puncturing or injuring any underlying organs. Oneway to minimize puncturing underlying organs during the closure processis to retract the tissue layers away from the underlying organs and tolimit or carefully control the ingress of suture introducers orretrievers beyond the tissue wall (peritoneal layer), for example in themanner described more fully below.

The closure device 102 in the present example includes a closure body116 (FIGS. 1-5). The body extends from a proximal portion 118 to adistal portion 120. Generally, the proximal portion 118 is used tocontrol and manipulate the closure device, and the distal portion 120forms a working structure to be inserted under the peritoneal layer. Thedistal portion 120 in the present examples is used to present a targetat a known and predetermined location where a suture can be reliablyplaced or retrieved, for example even without visualization, and in sucha way that suture bites can be made at optimal locations for formingreliable closures. For example, the distal portion 120 can be used as atarget for inserting one or more sutures through the fascial layer 112and into the target, and in another example, the distal portion 120 canbe used as a target for inserting a retrieval tool through the fasciallayer 112 to the target for retrieving a pre-disposed suture portionfrom the target and withdrawing the suture through the fascial layer 112and a tissue opening 106 to help in closing the opening.

The closure device 102 also includes an intermediate or middle portion122, which will be generally considered that portion of the closure body116 residing within the opening 106 during normal use. The middleportion 122 generally will extend between the outer surface of the skinlayer 110 and the peritoneal layer 114. The middle portion 122 includesat least one element that helps to reliably and repeatably place asuture introducer or retriever at the predetermined target site withoutthe operator having to substantially adjust or vary the direction ofmovement of the introducer or the retriever. In the present examples, asdiscussed more fully below, the at least one element in the middleportion 122 that helps to reliably and repeatably place a sutureintroducer or retriever at the predetermined target site is a channel orpassageway, for example a trans lateral passageway, through the body 116of the closure device.

Considering the closure device 102 in more detail, the distal portion120 in the present example includes a plurality of suture-receivingelements 124. The elements 124 may be wings that form targets for asuture introducer such as the needle assembly 104. The wings 124 extendoutwardly in substantially opposite directions from the closure body 116in the deployed configuration shown in FIGS. 1-5. They are substantially180° apart and extend substantially perpendicular to a central axis ofthe closure body. In other examples, the closure device could have asingle wing or plural wings, whether arranged in pairs or otherwise.When arranged in pairs, they can be arranged in two, four, six or morepairs, as desired.

The wings 124 (see also FIGS. 24-28) are pivotally mounted to respectiveportions of a mounting structure 126 at the distal end of the closurebody 116. The wings 124 are mounted at opposite sides of a channel orgroove 128 (FIG. 15) disposed along the central axis of the closurebody, so that the wings can pivot simultaneously between the opened ordeployed configuration shown in FIGS. 1-5 and a closed or insertionconfiguration shown in FIG. 12. The wings 124 are linked to and operatedthrough a pull rod 130 (FIGS. 1-3) through respective link arms orexpanders 132. Pull rod 130 extends upward into and is substantiallycentered on the central axis of the closure body 116 for longitudinalmovement within the body. Upward movement of the pull rod 130 pulls thelink arms or expanders upward to move the wings 124 from a collapsed orinsertion configuration shown in FIG. 12 to the expanded or deployedconfiguration shown in FIGS. 1-5. Downward movement of the pull rod 130within the body 116 fold the link arms 132 down relative to the body,thereby pulling the wings 124 downward to the closed configuration.Alternatively, pull rod 130 may be directly linked or engaged to thewings 124, eliminating the link arms or expanders 132. Upward movementof the pull rod 130 actuates the wings 124 from a collapsed or insertionconfiguration shown in FIG. 12 to the expanded or deployed configurationshown in FIGS. 1-5. Downward movement of the pull rod 130 within thebody 116 actuates the wings 124 to a closed configuration or geometrycapable of atraumatic insertion into the body.

Suitable precision machining, injection molding, casting or other suchforming of the wings, link arms 132 and pull rod 130, and theirpositioning and mounting to or within the closure body 116 allowsaccurate positioning of the wings 124 when in the deployed configurationshown in FIGS. 1-5. Therefore, when they are in the deployedconfiguration, the wing positions are accurately and reliably knownrelative to other points on the closure device. Likewise, the positionof any point on the wings 124 is also accurately and reliably knownrelative to any other point on the closure device. Therefore, withsuitable precision machining or forming of components on the closuredevice, the precise location of any point on a wing 124 is known and canbe used as a target for inserting or receiving a suture.

Each wing 124 includes a predetermined target location 134 (FIG. 1). Thetarget location can be used for reliably receiving a suture portion, forexample through an introducer, or for reliably retrieving a sutureportion previously placed at the target location. In the presentexamples, each wing 124 includes a target element 136 securelypositioned in the target area 134 of the wing, and partly underneath atarget approach opening 138 formed in a top surface 140 of the wing. Inthe present examples where the introducers or retrievers approach thetarget opening at an angle, the target approach opening 138 is alsoformed with a central axis at an angle, substantially parallel orconforming to the angle of approach of the introducer or retriever. Thetarget approach opening 138 includes a wall 142 (FIG. 10) shown asextending substantially parallel to the central axis 142A of theopening. However, the walls can be conical or other selected shape orcross-sectional configuration. The walls are also shown as circularcylindrical, but they can have other configurations as well.

The size and shape of the target approach opening 138 can be determinedbased on a number of considerations. When used in conjunction with asuture introducer, these considerations may include the sutureintroducer diameter, the flexibility of the introducer, the travellength of the introducer from an exit port on the closure body 116 tothe opening 138, and the desired tolerance between the expected range ofmotion of the tip of the introducer and the minimum openingcross-sectional configuration.

The target element 136 in the present example is a structure havingsubstantially the same shape as a cavity 143 in the wing 124 and sizedsufficiently so that the target element is reliably retained in thecavity. Alternatively, rather than being pre-cut to size and thenassembled, the target element can be insert molded directly into thecavity 143 and can fill the opening 138. The target element 136 isformed from a material sufficiently soft that the suture introducer cantraverse and embed the suture in the material. As shown in FIGS. 1-5,the material also is sufficiently soft so that the tip of the introducercan pass through the material. The target element is positioned so as tobe substantially centered under the target approach opening 138.

The target element includes a proximally-facing surface 144 (FIG. 10)with which the suture introducer comes into contact. In the presentexample, the surface 144 is initially unperforated, and lacks anyopenings, slits, slices or other breaks in the surface to ease thepenetration of the introducer past the surface. For situations wheremultiple closures are required in the same surgical setting and patient,the surface 144 can be used multiple times as long as the target element136 is able to maintain the embedded suture. The target element for thesurface and a substantial portion of the material below the surface issubstantially resiliently flexible. In one configuration, the targetelement is formed from a material that has a sufficiently highcoefficient of friction relative to the suture material so as tosuitably retain the embedded suture portion during normal operation. Forexample, it is desirable to ensure that the target element substantiallyretains the suture all the time while the wings are collapsed and theclosure device is being withdrawn from the trocar opening 106. Thesuture portion can then be cut from the closure device or more simplymanually pulled from the target element 136 material to allow anoperator to complete the closure of the trocar opening. In one example,the target element is formed from silicone rubber. Other materials (forexample biocompatible thermoset and thermoplastic materials) may be usedto suitably form the target having the desired characteristics.Additionally, the target material may consist of a single layer materialor may be of several layers, each layer having different characteristicsor properties designed to achieve the friction desired to hold thesuture in place but at the same time flexible enough to allow any needleor other suture carrying device to penetrate.

The pull rod 130 (FIGS. 1-11) controlling the positions of the wings cantake a number of configurations. In the present example, the pull rod isa substantially straight, longitudinally extending bar having arectangular cross-section extending from beyond the distal end of thebody through a similarly shaped channel in the middle portion and intothe proximal portion of the body. The pull rod 130 is positioned on acentral axis of the body. The pull rod is substantially rigid so as toreliably transmit a force to enable movement of the wings 124 withminimal to no bending. The proximal end of the pull rod 130 is securedby a pin 146 to an actuator mechanism so that when the actuatormechanism is moved, the pull rod 130 and therefore the wings 124 arealso moved. The pin 146 is positioned to move axially within a pair ofoppositely formed slots 148 (FIGS. 11 and 16 and 20) in a side wall ofthe proximal portion of the closure body 116. The slots are formed so asto allow easy translation of the pin within the slots. Alternatively(not shown), the pull rod 130 may be directly linked or engaged with anactuator mechanism by means of a T-bar end configuration or the like,eliminating the need for a pin 146. Further design alternatives (asshown in FIGS. 35-39) include elimination of the actuator sleeve 150 andfinger rings 154. In this configuration, the top ring 164 is configuredto move relative to the main body of the closure device and serves asthe actuator mechanism for moving the pull rod 130 upwards or downwards.

In the present example, the pin 146 is fixed to the pull rod and to anactuator sleeve 150 on the closure body 116. The sleeve 150 has asubstantially cylindrical body 152 (FIGS. 10-14) configured to slide upand down along an outer surface of the proximal portion of the body. Thepull rod 130 and the sleeve 150 are substantially axially fixed relativeto each other.

The sleeve 150 is an actuator device that an operator can use tomanipulate the wings 124. Manipulator elements such as finger rings 154on the sleeve 150 make it easier for an operator to move the actuatordevice up and down over the closure body 116. Other manipulator elementsmay be used, for example grip surfaces, curved trigger-shaped surfacesand the like. The finger rings 154 are oriented diametrically oppositeeach other on the sleeve body 152 for convenient manipulation by theoperator.

The actuator sleeve 150 may include a biased locking or latching elementhaving a cap or sleeve 156 (FIGS. 1-3, 5, and 12) secured on a boss orpost 158 (FIGS. 13-14) on an outside surface of the cylindrical body152. The locking element 156 in the present example is biased inward andis movable over the post 158 substantially radially relative to the body116, and includes a locking pin (not shown) fixed to the cap. Thelocking pin is insertable into and removable from one of two (in thepresent example) locking openings 160 and 162 (FIGS. 12 and 16). Lockingopening 160 locks the sleeve 150 and therefore the wings 124 in adeployed configuration, and the locking opening 162 locks the wings 124in an insertion configuration such as is shown in FIG. 12. The springbias in the locking pin keeps the lock in place until manually unlocked,and locks the sleeve 150 in place as soon as the pin is aligned with agiven opening 160 or 162. Alternatively, the lock can be a set screw orother manual securement, an umbrella-style latch mechanism, living hingeor the like. The pin 146 in the pull rod and the slots 148 help to keepthe sleeve 150 from pivoting about the body so that the locking pin willno longer align with one of the openings 160 or 162.

A top ring 164 (FIGS. 1-7 and 10-12) is fixed to the top of the proximalportion of the body 116. The top ring can be used as a thumb ring by theoperator and is oriented so as to extend substantially parallel to thefinger rings 154 and substantially orthogonal to the wings 124 whendeployed. The operator can use the top ring as a reference or base as towhich the actuator sleeve 150 is moved back and forth. A compressionspring 166 (FIGS. 10-11) is positioned in a bore 168 and biases theactuator sleeve 150 away from the top ring 164 by way of contact betweenthe spring 166 and the pin 146. Therefore, the closure device is biasedso that the wings are in their insertion configuration (FIG. 12) unlessthe sleeve 150 is fixed by the locking pin in the opening 160.

In the present example, the closure device includes an opening 170(FIGS. 1, 9 and 17), which opens into a passageway 172. In the presentexamples, a second passageway 174 includes a respective opening 176(FIG. 17) substantially identical to but diametrically opposite from theopening 170. Only the opening 170 and the passageway 172 will bedescribed in detail, and it will be understood that the secondpassageway 174 and second opening 176 are substantially identical to thefirst. Other openings and passageways may be included to correspond toadditional target elements other than the illustrated wings 124 such asare shown in FIG. 1.

The opening 170 is formed in the proximal portion of the closure body116, and the passageway 172 extends from the opening 170 at an angle,for example trans-laterally of the body 116. The passageway terminatesat an exit opening 178 (FIGS. 3-4) formed in a side wall of the closurebody 116 in the middle portion 122 of the body. Generally, thepassageway is substantially straight and includes a center axis thatpasses through substantially the center of the target access opening 138in the corresponding wing 124 (FIG. 1). The passageway can be configuredin length and cross-sectional dimension in conjunction with a sutureintroducer such as the needle assembly 104 so that the tip of the needleor suture introducer assembly 104 substantially always passes throughthe opening 138, even without visualization. Alternatively, thepassageway 172 can be slightly curved between the entry opening 170 andexit opening 178.

The opening 170 in the present example opens into a conical orfunnel-shaped lead-in or approach to the rest of the passageway 172. Theapproach makes it easier to introduce the needle assembly 104 to thepassageway. The remainder of the passageway to the exit opening 178 hasa substantially constant cross-sectional configuration and area untilreaching the external surface of the closure body 116. In the presentexamples, the passageway 172 is substantially circular in cross-sectionand in one example is sized to smoothly accommodate the needle shaft ofthe needle assembly 104 and two times the cross-section of a suture toaccount for a double backed portion of suture, without wear on thesuture or binding in the passageway.

As can be seen by comparing FIGS. 1-12, the passageway 172 extends fromthe opening 170 on one side of the finger rings 154 to the wing 124 onthe opposite side of the finger rings. The passageway 172 does not crossthe rectangular bore in which the pull rod 130 travels. Additionally,respective passageways do not intersect, thereby ensuring that asubsequent needle passage does not interfere with or damage apreviously-positioned suture. The actual length of a passageway may beselected as a function of the vertical height or axial length over whichit is desired to have the suture pass through the tissue adjacent theexit opening 178 to the corresponding target area 134. The overalllength may also be selected as a function of the axial position of theopening 170. However, as described more fully below, it is desirable toestablish a relationship between the axial height from the exit opening178 to the top of the wing 124 and the lateral distance from the closurebody 116 to the center of the target opening 138.

When the closure device 102 is used to pass a suture through thesurrounding tissue and into a target area 134, it may include a sutureescape slot such as opening 180 extending from the entrance opening 170to the exit opening 178. The slot opening 180 is a substantiallystraight opening formed into the wall from the surface of the closurebody 116 to intersect the passageway 172 along with the entrance andexit openings 170 and 178, respectively. The slot opening 180 iscontained in a plane that also contains the central axis of thepassageway 172. Consequently, a suture passing through the passageway172 can be relatively easily manually extricated from the passageway bythe operator by shifting the suture outwardly through the slot opening180 facilitating a more rapid procedure. The width of the slot openingmay be slightly greater than the maximum cross-sectional dimension ofthe suture. However, the largest gap spacing of the slot opening is lessthan the smallest cross-sectional dimension of the needle or otherintroducer element extending along the passageway, so that the sutureintroducer does not move laterally significantly as it traverses thepassageway. Other configurations can omit a suture escape slot.

The closure body 116 includes one or more surfaces such as grippingsurfaces 182. The gripping surfaces are positioned on a proximal portionof the closure body, and in the present examples below the actuatorsleeve 150. The gripping surfaces may be finger grasping or grippingsurfaces distal of the openings 170 and 176 but still proximal of themiddle portion 122 of the closure body. The gripping surfaces mayinclude surface configurations complementary to finger curvature, andthey may include surface variations or textures for helping the operatorto reliably grasp the body of the closure device. In the illustratedexample, the surface variations include transversely extending ridges184 (FIGS. 7 and 11). In other configurations, the surface variationsmay include grooves, knurling, dimples, surface texture variations orother configurations to help the operator reliably grasp the body of theclosure device. In the illustrated example, the gripping surfaceincludes curved surfaces as well as surface variations. Additionally,the gripping surfaces include oppositely facing, orthogonal finger gripson the body.

The illustrated example includes, though closure devices can omit one orthe other or both, a finger shield or guard 186 around the openings 170and 176 for the passageways and proximal of the grasping areas. Theshield or guard 186 helps to protect the operator's fingers or hand fromaccidental needle stick as a needle is introduced into one or the otherof the openings. In the illustrated example, the guard or shield ispartly distal of the openings but still proximal of the middle portion122 of the body. This allows the operator's finger or fingers to beplaced distal of the guard while still above the surface of the skin,and while a suture is being introduced to an opening in the closuredevice. In the present example, the guard or shield has a flat proximalsurface 188 and an elliptical perimeter. The guard or shield issubstantially planar and is thick enough to withstand impact and bendingduring normal use.

In the illustrated example, the openings 170 and 176 are formed in theproximal surface 188 of the guard or shield 186, on substantiallydiametrically opposite sides of the center axis of the body. The slots180 also extend through the guard or shield and outward to the perimeterthereof In the present example, the grasping surfaces 182 are orientedto extend in a direction substantially parallel to the major axis of theelliptical guard or shield. Other configurations and relative dimensionsof the gripping surfaces and the guard or shield may also be used.

A substantial portion of the proximal area of the closure body 116 issubstantially cylindrical, for example to permit the actuator sleeve 115to slide along the body surface. Other configurations for the outersurface adjacent the actuator sleeve may also be used while stillpermitting the actuator sleeve to open and close the wings 124. Thefinger grasping surfaces are noncircular and non-cylindrical to makeeasier the grasping and manipulating the closure device. The remainderof the body of the closure device is substantially cylindrical in theperimeter surface, for example to easily accommodate the shape of thetrocar opening. The middle portion 122 of the closure body 116 has asubstantially straight cylindrical sidewall, except for the slots 180and the exit openings, and it extends to a first taper surface 190. Thetaper surface 190 extends distally to a reduced diameter body surface192 between the taper 190 and the mounting structure 126 for the wings.The taper surface 190 is configured and placed axially on the closurebody to permit a portion of the fascial layer 112 ingress against theclosure body and further underneath the path of the suture-carryingneedle.

The closure body 116 in the present example includes at least oneindicator or marker for indicating a location of the closure bodyrelative to surrounding tissue. In the illustrated example, a proximalindicator 194 is formed in at least part of the body surface and extendsat least partly around a perimeter of the body at a given axial positionon the body. The proximal indicator 194 can be used to provide theoperator with an indication of the maximum depth to which the operatorshould insert the device into the trocar hole relative to the skin layerprior to commencing the closure procedure with the closure device. Theproximal indicator in the present example is the most proximal indicatorof a plurality of indicators. The proximal indicator helps to reduce thepossibility that the closure device or needle or suture introducercomponent is introduced too great a distance beyond the abdominal wall.The axial position of the proximal indicator away from the closed wings124 is selected as a function of typical tissue thickness for openingsfor which the closure devices to be used. Once the maximum tissue depthis reached, visualization or other indicators can be used to confirm ifdesired that it is appropriate to deploy the wings 124. A proximalindicator can also be used for other purposes.

In the present examples, an intermediate indicator 196 is positionedcircumferentially around the closure body 116 in the middle portion 122.The intermediate indicator 196 is positioned slightly below the exitopenings, and otherwise substantially encircles the body. Theintermediate indicator at the position below the exit openings can beused to note the location of the exit openings for example relative tothe fascial layer 112. For example, as can be seen in FIG. 2, theintermediate indicator 196 occurs below the exit openings but above thestart of the fascial layer 112. Consequently, introduction of a suturethrough the fascial layer will have the suture pass through the fullthickness of the fascial layer, for example as illustrated in FIG. 2. Itis desirable to have the indicator 196 slightly below the exit openingsso that the operator can confirm that a suture introduced through theclosure device will transit the entire thickness of the fascial layer.This indicator 196 also acts as visual warning to the operator that thepatient's soft tissue bed may be too insubstantial in terms of thicknessand, if the indicator is at or near the skin layer upper surface, thatthe needle will exit at a point above the skin level instead of below itas desired.

A distal marker or other indicator can be used to indicate a desiredposition for the closure device within the trocar opening relative tothe peritoneal layer to begin or transition the closure device from aninsertion configuration to a deployed or open configuration. Forexample, indicator 198, when visible beyond the peritoneal layer,indicates that the wings 124 have sufficiently cleared the peritoneallayer and can be opened to safely deploy the wings in the typicallyinsufflated abdominal cavity. The wings can then be deployed by pullingup on the finger rings 154, thereby sliding the actuator sleeve 150proximally to pull up on the pull rod 130.

In a further example, a distal marker 200 (FIG. 16) may be positioned onthe body proximal of the body distal end and of the wings 124. Thedistal marker 200 can be used when the closure device is preloaded withone or more sutures before insertion into the trocar opening. When thewings 124 are preloaded and deployed, and the peritoneal layer isproximal of the distal indicator 200, there is sufficient clearancebetween the peritoneal layer and the target area 134 on the wings for aretriever such as one with jaws or a clasp to actuate, secure a sutureportion, and withdraw the suture portion through the fascial layer andoutside the skin layer. Other markers or indicators can also be used asdesired.

One or more of the indicators may be formed by grooves or other surfacediscontinuities visible or that can otherwise be sensed on the closurebody. The indicators can be painted, pad printed, texturized, or mayinclude some other detectable material or indicator for sensing theposition of the indicator relative to the surrounding tissue.

In the example shown in FIG. 2, the proximal indicator 194 and thedistal indicator 198 are formed on the closure body 116 to indicate themaximum tissue depth for insertion of the closure device. The spacingbetween the two indicators is determined by the maximum expected tissuedepth for a large population of expected patients, and the twoindicators formed accordingly. Other populations such as morbidly obeseor exceptionally thin patients may lead to adjustments on the locationsof these indicators. The intermediate indicator 198 is positionedaxially on the external surface of the closure body slightly below theexit openings for the passageways 172 and 174. The exit openings in turnare positioned on the closure body an axial distance above the deployedlevel of the wings 124 sufficient to permit traversal by thesuture-carrying needle of the entire thickness of the fascial layer 112.

One or more of the indicators can therefore be used for visual or otherforms of confirmation for the operator that the positioning of theclosure device will achieve the desired suture placement and closureconfiguration. Similarly, with the closure device having the spacingconfiguration such that the exit openings are a predetermined distancefrom the upper level of the deployed wings, and such that the targetareas 134 on the wings are spaced a predetermined distance from theadjacent body surface, the operator knows that proper positioning of theclosure device will produce the desired suture bite in the fasciallayer. Therefore, with the intermediate indicator 196 located slightlybelow the exit openings, and the distal marker 198 located at the levelof the upper wing surfaces, any visual inspection that reveals theperitoneal layer resting on the wings 124 and the intermediate locator196 above the fascial layer, gives the operator secondary confirmationthat the desired suture bite in the fascial layer results.

In one configuration of a closure device 102, such as where the deviceis used as a target for sutures introduced after the closure device isfully deployed with the wings 124 under the peritoneal layer 114, theclosure device 102 can be given a design to achieve a desired suturebite of the fascial layer. For the average patient population, a desiredsuture bite is one where the suture traverses the peritoneal layer 114(FIG. 2) about 1 cm from the edge of the trocar opening 106. Therefore,the center of the target access opening 138 in the top of the wing 124can be positioned a distance 202 of 1 cm measured perpendicular to theadjacent surface of the closure body. Therefore, when the closure device102 is positioned in the trocar opening as depicted in FIG. 2, thefascial layer 112 closes around the distal portion, including the taper190 of the closure body. The target access opening 138 is thenpositioned at the peritoneal layer 1 cm from the adjacent edge of thetrocar opening. Likewise, visual inspection will reveal that the distalindicator 198, which is 1 cm away from the target access opening 138, isproperly positioned relative to the peritoneal layer, and subsequentinsertion of sutures will produce the desired suture bite for thefascial layer.

Likewise in the configuration of the closure device described in theimmediately preceding paragraph, for average patient populations, havingthe exit openings 178 for the suture carriers sufficiently spaced fromthe tops of the deployed wings 124 will ensure that the sutures willtraverse the entire thickness of the fascial layer 112. Therefore, asdepicted in FIG. 2, the exit openings 178 of the passageways for thesuture carriers are placed a distance 204 axially above the tops of thedeployed wings 124 equal to about 2.5 cm. Similarly as depicted in FIG.2, the suture-carrying needle of the assembly 104 enters the fasciallayer 112 well away from the trocar opening wall and traverses theentire thickness of the fascial layer. Likewise, where the fascial layercloses around the tapered portion 190 and the distal portion of theclosure body above the wings 124, the suture exits the peritoneal layerabout 1 cm outward of the trocar opening wall. Therefore, the distances202 and 204 can be considered to form a right triangle where the twoperpendicular sides have a ratio of 2.5:1. A closure device where thetarget access opening 138 is 1 cm away from the adjacent body wall andthe exit openings are 2.5 cm above the deployed wings will produce themost desired or optimal suture bite. Therefore, one desired ratiobetween the perpendicular sides of the triangle is approximately 2.5:1where the target access opening is on the wing 124 1 cm away from thebody. Where the distance 202 is 1 cm, the ratio can be less than 2.5:1but it is still desirable that the suture traverse the entire thicknessof the fascial layer 112. This result is achievable by configuring theclosure device with these dimensions and suitable tolerances in thepassageways and by configuring the needle assembly 104 so that theneedle shaft and its tip as a result do not bend significantly out ofthe linear path from the exit to the target defined by the passageway174. The target access opening in other examples can be as little as 0.5cm and may be as much as 2.0 cm away from the body (measureperpendicularly). Also in other examples, the exit openings can be asclose as 1.0 cm above the top of the wings or space as much 4.0 cm away.While the closure device can be designed with other configurations toproduce different suture bites, it is believed that the closure devicesdescribed can reliably and repeatably produce the desired suture biteand closure configuration. Additionally, while visualization of theindicators or markers is useful for confirming proper positioning,precise manufacture of the closure device and the needle assembly orother introducer assembly can reliably and consistently produce theintended result in the tissue beds likely to be encountered in aclinical setting.

A suture introducer can be used with the closer devices discussed hereinas well as with other tissue closure devices. One example of a sutureintroducer includes the needle assembly 104 (FIGS. 29-31). The needleassembly 104 includes a proximal handle portion 300 and a distal needleportion 302. The handle 300 includes a disc-shaped cap 304 having asubstantially flat end face and an outer diameter approximately the sameas the maximum outer diameter of the rest of the handle. In the presentexample, the handle 300 includes a pair of oppositely-disposed fingergrasping surfaces 306, shaped to optimally conform to curved fingersurfaces. The grasping surfaces or textures may include surfacevariations 308 to help in reliably gripping the handle and manipulatingthe needle assembly. In this example, the grasping surfaces 306 arepositioned immediately distal of the cap 304.

The handle may also include relatively shallow concave surfaces 310extending on opposite sides of the handle over a substantial length ofthe handle, and on the same sides as the grasping surfaces 306. Thesurfaces 310 also help the operator to properly hold and manipulate theneedle assembly in a closure procedure.

The needle 302 includes a needle shaft 312 extending over a substantiallength of the needle. The needle terminates at a needle tip 314, havinga strength and configuration suitable for maintaining the point andstrong enough to penetrate the resilient material of the target element136. The needle 302 extends from the base 316 of the handle over apredetermined length to the tip 314. The base 316 is sized or otherwiseconfigured to contact the shield or guard 186 so that further ingress ofthe needle is prevented. Therefore, the predetermined length of theneedle 302 is selected such that, when the base 316 of the handlecontact the guard 186 of the closure assembly, the needle tip 314extends no more than a predetermined distance beyond the target element136. In one example, the predetermined distance beyond the targetelement 136 may be less than or approximately the same as the distancethat the pull rod 130 extends below the bottom surfaces of the deployedwings 124. Pre-selecting the amount of exposed needle tip extendingbeyond the wings 124 helps to reduce the possibility of unintendedneedle stick, for example of internal organs within the insufflatedabdominal cavity. The handle or other parts of the needle assembly can,in addition or instead, have other surfaces for contacting the closuredevice to limit further ingress of the needle assembly.

The needle includes a distal end portion 318 having a suture retainingor carrying portion in the form of a groove 320. The groove is formed inone side surface of the needle shaft 312 starting at an axial positionadjacent where the needle point 314 transitions to the full needle shaftdiameter. The groove includes an entrance portion 322 formed in part bya proximally-extending ramp surface 324 and a protrusion 326. The largerspacing between the ramp surface 324 and the protrusion 326 is aboutseveral times the diameter of the suture to be used with the needle 302.The smallest spacing between the protrusion 326 and the ramp portion 324is approximately the diameter of the suture.

The protrusion 326 extends distally from the needle shaft 312 and it isspaced apart from a long side 330 of the groove. The protrusionconverges on the open side and on the groove side to a rounded tip 332to minimize any damage to the suture when the suture contacts theprotrusion. The minimum spacing for the groove between the long side 330and the protrusion side 334 is slightly less than a diameter of thesuture to be used with the needle, for example a size 0 suture. Theminimum spacing for the groove is selected so that the suture,represented schematically at 336, requires a proximally-directed forceto pull the suture past the restriction in the groove, at which pointthe suture would be depicted in FIG. 31 as squeezed or elongated in thedirection of less constriction until the suture is past the restriction.The protrusion 326 can be formed as a rigid section or as a flexiblesection such that it can be deflected during suture loading or duringthe release of the suture. For example, the operator or a machine cangrasp the suture on opposite sides of the groove and pull the sutureinto the groove 320 in the proximal direction along the ramp 324 andagainst the resistive force created by the restrictive spacing betweenthe walls 330 and 334. The restrictive spacing is preferably such as tokeep the suture from falling out of the groove by force of gravity ifthe needle and suture are pointed downward with the suture hanging fromthe groove 320. The restrictive spacing is selected so that a greaterforce is required to remove the suture from the groove, and the greaterforce is on the order of the frictional force developed between a sutureportion and the material of the target element 136, such as siliconerubber, when a suture portion is embedded in the target material. Therestrictive spacing of the groove can be formed by cutting (for example,EDM, laser cutting), grinding or otherwise forming the groove to have adimension smaller than the outer dimension of the suture, biasing theprotrusion 332 toward the groove wall 330 or in other ways.

The needle assembly also includes an indicator 338, in the presentexample on the handle, for indicating the relative orientation of thegroove 320 to ease loading of suture especially in dark operating roomsas the groove feature is discrete and could be difficult to see clearly.The indicator can also be used to determine the orientation of thegroove and the suture therein when the needle assembly and suture havebeen introduced into a passageway in the closure device or further intothe tissue or target. In the illustrated example, the indicator 338 is alongitudinally extending ridge formed on the handle and extendingsubstantially the full length of the handle. A gap may be formed betweensections of the ridge. The indicator 338 may be positioned during use sothat the groove 320 and the supported suture in the target element 136face away from the body 116 of the closure device.

Another example of a suture needle, and one that can be used with any ofthe examples of closure devices described herein, includes a morepronounced offset opening. In the present example, a needle combinationor suture introducer 350 (FIGS. 32-34) may be substantially identical tothat described previously, except for the differences described inconnection with and illustrated in FIGS. 32-34. In the present example,the handle 352 includes a pronounced and tactile indicator or marker 354in the shape of an arrow or triangle, with an apex directed toward theneedle tip 356. The marker 354 is on the same side or at the sameangular or arcuate position on the needle shaft as is the entranceportion 358 of a suture-carrying groove 360 (FIG. 33B). Alternatively,the needle can have a handle portion configured in any of the other waysdescribed herein, or other configurations known to those skilled in theart.

The needle shaft extends along a central axis 362 (FIG. 33A) to thesuture-carrying groove 360 defined by a groove formed in the needleshaft between a protrusion 364 and the remainder of the needle shaft. Inthe present example, the terminus or distal end of the protrusion 364curves or bends slightly inward toward the central axis 362 to furtheroffset or bias its outer surface inside of the outer-most perimetersurface 366 of the needle tip base 368 and/or to reduce the size of theopening for the suture. The characteristics and function of the opening358 and groove 360 are substantially the same for the suture and its useas described herein. In the present example, the protrusion 364 isrecessed below the envelope defined by the outer perimeter of the needletip base 368 (perimeter 366 shown in FIG. 33C) than is the rounded tip332 in the example described with respect to FIGS. 29-31. As can be seenin the cross-section of FIG. 33C, the protrusion 364 is positionedsignificantly interior to the perimeter 366 of the needle tip base 368.The protrusion 364 is positioned approximately halfway between theouter-most perimeter surface 366 of the needle tip base 368 and thecentral axis 362 of the needle shaft. In this configuration, thepossibility of tissue or other adjacent material engaging the free endof the protrusion 364 is even further reduced while minimizing trauma tosaid tissue or adjacent material. Furthermore, the protrusion 364 may beformed as a flexible section by reducing its dimension (e.g. thickness)in order to provide flexibility which allows it to deflect towards thecenterline of the needle when an external load or compression force isapplied on the outer perimeter of the protrusion 364, as in the case ofa tissue recoiling when the needle is being inserted through the tissue.The deflection further captures or secures the suture while beinginserted into the tissue and through the target element 136 of theclosure device.

Alternative to the opening being offset, the opening 358 may beconsidered recessed below the adjacent surfaces of the needle tip base.In this example, at least the free end of the protrusion externalsurface is positioned closer to the central axis of the needle than isthe adjacent surface of the needle tip base at the same arcuate orangular position about the central axis of the needle as the protrusion(vertically downward when viewing the cross-section in the direction ofFIG. 33C). From a side view, such as that shown in FIGS. 33A and 33B,the top surface 370 of the protrusion at the opening and at its free endis higher than the lower surface 372 of the needle tip extendingparallel to the needle axis (FIGS. 33B and 33C). In the configurationshown in FIGS. 33A-33C, the center of gravity of the needle tip base 368is significantly below (as viewed in FIGS. 33A-33C) the central axis362. Additionally, the perimeter surface profile of the needle tip base368 extends significantly radially outward relative to the outerboundary of the protrusion 364, which provides a shadow or protectionbenefit to the protrusion 364, when the needle is viewed proximally fromthe distal end.

In the configuration of the needle end shown in FIGS. 32-34, the size ofthe entrance portion or opening 358 to the groove 360 is smaller, asmeasured in an axial dimension, than that in the example of FIGS. 29-31.The distal-most tip of the protrusion 364 is closer to the ramp surface374 forming part of the entrance portion to the groove.

The recessed protrusion can be formed in several ways. In one example, aprotrusion, boss or other extension can be formed on the needle tip base368 so as to move the center of mass of the needle tip base away fromthe central axis 362. In another example, the groove 360 can be otherthan coaxial with the central axis 362, for example so that the distalend portion 370 of the protrusion 364 is closer to the central axis 362than is the base of the protrusion 364 where the protrusion 364 meetsthe needle shaft.

In another example, the recessed protrusion is produced by radiallyoffsetting the needle tip from the needle tip base. In one example, thebase of the needle tip adjacent the opening is enlarged or upsetrelative to the needle shaft (for example that portion of the needleshaft supporting the protrusion.) The needle tip base adjacent theopening 358 can be bent at an angle to the central axis so that acentral axis of the base 368 diverges away from the needle shaft. Thebase is offset by providing an offset portion, for example 376, bybending the material between the needle shaft and the base 368. The base368 can be bent again so that the central axis of the base 368 is at anangle to the central axis 362. The needle tip 356 supported by the base368 can then be ground or otherwise formed into the shape illustrated.In the example shown, the triangular portion (as viewed in FIG. 33A) ofthe needle tip 356 is substantially symmetric about the central axis362. In another example, the needle tip and base can be formed byremoving (such as by grinding) less of the material adjacent the openingcompared to the material on the side away from the opening. Thestructure and use of the needle is otherwise the same as the otherexamples described herein.

In another example of a tissue closure device 400 (FIG. 35), which mayhave any or all of the features and configurations of the tissue closuredevices described herein, which may be used with any of the sutureintroducer or needle assemblies described herein, for which may be usedwith any of the methods described herein, an indicator 196A is provided,and/or one or more suture-receiving wings 124 may be provided to improvethe resulting tissue closure configuration in some patient populations,for example obese patients. In the present example, the tissue closuredevice is substantially identical to those described herein except thatthe outer diameter of the body 116/116A is approximately 14 mm insteadof approximately 12 mm for the configuration described with respect toFIG. 1, the height or length H1 from the wings 124 to the bottom of theguard 186 is approximately 7 cm rather than approximately 5 cm, and theheight H2 of the intermediate indicator 196A is approximately 4 cmrather than approximately 2.5 cm above the deployed wings 124, and thelateral distance W1 is approximately 1.5 cm rather than 1 cm. In thisconfiguration, the ratio of H2:W1 is approximately 2.7 rather than theapproximately 2.5 for the configuration described with respect toFIG. 1. It is contemplated that it is possible that the ratio couldrange from approximately 2 or less to approximately 3 or more, while aratio between two and three has been found to be suitable. The ratio canbe increased, for example, by increasing W1, for example by changing theangle of the slots through which the needle passes, or curving the slotsso that the needle enters the target on the wings 124 further from thebody 116A. Other ways can also be used to increase the ratio. The ratiocan be decreased by adjusting these parameters in the other direction.

In the present example of FIG. 35, the intermediate indicator 196A isalso placed substantially at the exit opening for the needle, andotherwise substantially encircles the body 116A. The intermediateindicator 196A has substantially the same structure and function as theintermediate indicator 196, but placed at a different axial positionrelative to the wings 124. Consequently, when the wings 124 are broughtup against the peritoneum, the adjacent surface of the peritoneum servesas the datum line or baseline for determining where a needle and sutureare to be introduced there-above to provide the desired suture bitethrough the peritoneum. In the present example of FIG. 35, thedimensions and ratios are believed to provide the optimum suture bitefor the majority of obese patients so that the suture will pass throughthe full thickness of the fascia layer, for example as illustrated inthe comparable configuration of FIG. 2. When the wings 124 are retractedagainst the peritoneum, this configuration allows the user to index offthe peritoneum and to more reliably estimate where the fascia would beso that the suture can be introduced immediately above the fascia. Byindexing off the peritoneum, sutures can be introduced more reliably atthe desired locations to optimize the integrity of the closure and toincrease patient to patient consistency of closure. For obese patients,this is done with the closure device having the configuration describedwith respect to FIG. 35, and for patients other than obese patients thiscan be done with the closure device described with respect to FIGS. 1and following.

The diameter of the body 116A is slightly larger in the presentconfiguration, for example for obese patients, for example toaccommodate a possibly larger tissue opening left by larger trocars.This configuration increases the possibility that the desired level ofinsufflation or pneumoperitoneum can be maintained or preserved as wellas possible.

In another example of apparatus that can be used for closing a tissueopening, and where the apparatus reflects one or more methods that canbe used for tissue closure, a closure device 502 (FIGS. 36-39) can beused with any of the needle assemblies described herein, or with othersuture introducers or needles. However, for purposes of the presentexamples, the closure device 502 will be considered as being used withone or another of the needle assemblies described herein. The closuredevice 502 in the present example includes a closure body 516 extendingfrom a proximal portion 518 to a distal portion 520, serving a functionsimilar to that described above with respect to the embodiments of FIGS.1 and following.

In the present example, the distal portion 520 includes a plurality ofsuture-receiving elements in a pair of wings 524 configured andoperating in a manner similar to the wings 124, except that at least oneof the wings includes a plurality of suture-receiving elements. In theexample illustrated in FIGS. 36-39, each wing includes a pair ofsuture-receiving elements (not shown) accessible through respectivetarget-approach openings 538A-538D. Each opening in the pair ispositioned on the wing so that the openings are substantially symmetricwith respect to a centerline or center plane through the wing, andinclude bores or other channel configurations for reliably receivingneedles or other suture-carrying elements. The wings 524 in the presentexample are arranged in pairs, substantially opposite each otherrelative to a central axis of the closure device. As with otherconfigurations of the closure devices, additional wings can be included,in pairs or otherwise, with single openings, pairs of openings, or morethan two openings in at least one of the wings, in some of the wings, orin all of the wings.

In the present example, the closure device 502 includes an opening 570which opens into a passageway 572. In the present example, there is onepassageway corresponding to respective openings 538, namely openings570A, 570B, 570C, and 570D, respectively. Each of the openings haverespective passageways 572. The openings, passageways and openings 538have the same or similar structures, functions and uses as the openings170, passageways 172 and openings 138. Other openings 570 andpassageways 572 may be included to correspond to respective targetelement other than the illustrated wings 524.

In the present example, the body 516, openings and passageways areconfigured so that an opening 570 above one side of one wing (forexample 570D shown in FIG. 36) opens into a passageway that would directa needle or other suture carrying device to the opposite wing in thepair of wings, but on the same side of the opposite wing has side onwhich the opening originates. Therefore, as shown in FIG. 36, opening570D is directed to the target-approach opening 538D. Likewise with theother openings and passageways. Alternatively, another closure devicemay be configured so that an opening 570 above one side of one wingopens into a passageway that would direct a needle, for example, to theopposite wing in the pair of wings and on the opposite side of the wingfrom which the opening 570 began. For example, as the openings arelabeled in FIG. 36, the latter-described configuration would have theopening 570D correspond to the opening 538C. Other combinations are alsopossible.

It is noted that any of the closure devices discussed herein, and thesuture-receiving elements used with them, can be configured assingle-wing closure devices. The method of closure may vary depending onthe number of wings on the closure device, but the configurations of thewings described herein along with the components incorporated or thatcan be made part of a given wing can be incorporated into a number ofclosure device configurations. Additionally, the suture-receiving ortarget elements described herein can be incorporated into a number ofclosure devices, whether with or without wings as described herein.

The closure device in the example of FIGS. 36-39 may be suitable forclosure of larger openings than that described with respect to FIG. 1and following. For larger openings, the cross-section of the body 516may have a larger diameter, or may have a different shape, for exampleoval, as desired. For example, and oval cross-section may facilitatehaving oppositely-configured pairs of openings and passageways such asthose shown in FIGS. 36-39. Additionally, noncircular bodies may beuseful for closure of noncircular tissue openings, for example tissuetears or longitudinal tissue openings.

The target element 136 (FIG. 1) may take a number of configurations, andit may be implemented in a number of ways. In the example shown in FIG.1, the target element may have one configuration in which the targetelement in the wing 124 is a monolithic structure, for example molded inplace. In other examples, the target element may be inserted or insertedand removed. Additionally, as described below, the target element can bepart of an assembly, which assembly is placed in a wing of the closuredevice, such as wing 124, having a configuration appropriate forreceiving a target assembly. In these examples, the assemblies will allhave a target element having one or more of the characteristics of thetarget elements described herein, including the materialcharacteristics, ability to hold a suture in place, as well as any orall of the other characteristics suitable for target elements inapplications of closure devices such as those described herein. Targetelements incorporated into target assemblies will have shapes, sizes andsurface characteristics that may be different from those of the targetelement 136 described herein.

In the following examples of target assemblies (FIGS. 40-50), the targetassemblies are formed as two-piece assemblies. They can also be onepiece assemblies, for example if they are co-molded in such a way thatthey appear to be one piece assemblies, even though there may be two ormore different types of materials included in the assembly. They canalso have more than two pieces. However, for purposes of the presentexamples, the target assemblies are two-piece structures.

In one example of a target assembly, for example target assembly 600 inFIGS. 40-41, the target element 602 is positioned at least partly insidean outer component 604. The outer component 604 typically includes atleast one wall 606 defining an opening in which the target element 602is positioned for allowing a needle or other element to contact thetarget element. The outer component 604 may be any number of elements,including a cartridge, a holder, a carrier, a housing, or similarstructure. The outer component 604 supports the target element andpositions the target element within a suitable opening in the wing 124,such as wing 124A. In the present examples, the outer component reliablysecures the target element within it, for example so that the targetelement is not removable from the outer component without substantiallycompromising one or the other of the elements of the assembly. While itis possible that the target element can be removable from the outercomponent 604, for example for replacement and reuse, the presentexamples will treat the target assembly 600 as being a one-time usecomponent and disposable.

In several examples of target assemblies described herein, includingtarget assembly 600, the outer component 604, sometimes referred toherein as an insert, includes one or more retention features. Aretention features used to help hold the target assembly in place in awing during normal applications. A retention feature may take the formof surface configurations, for example, surface textures, surface shapesas well as complementary surface configurations, namely surfaceconfigurations that are complementary to corresponding surfaces in awing. For example, the surface configurations may be mating surfacesbetween the insert and adjacent surfaces in the wing. Alternatively, aretention feature may be a mechanical element that is moved in such away as to hold the target assembly in place, for example a slidemechanism, cover or the like.

In the example of the assemblies shown in FIGS. 40-41, the targetassembly is held in place in the wing 124A through engagement of adetent on an outer or exposed surface on the insert 604 engaging acomplementary surface on the wing. In the present example, the insert604 includes a vertically extending (as viewed in FIG. 40) detent 608approximately centered on a distal side surface of the insert 604. Thelength of the detent is preferably sufficient to reliably engage thecomplementary surface on the wing, and in the present example extendsthe height of the vertical face of the distal surface. In the presentexample, the detent 608 extends from a medial groove 610, formed toaccommodate adjacent structures such as pull rod 130 and link arms 132,to an upper transition surface 612 curving inward to a top surface ofthe insert. In the present example, the remainder of the surfaces of theinsert and the target element 602 substantially conform to the adjacentsurfaces of the wing 124A. As shown in FIG. 41, the plan view of theinsert 604 is substantially square in outline, and a lateral receivingslot 614 in the wing has substantially straight walls laterally exceptfor the distal wall 616. An approximate midpoint of the distal wall 616,a vertically extending groove 618 is formed in the distal wall. Thegroove 618 receives and helps to hold the detent 608, thereby helping toretain the insert in the lateral slot.

In use, the target assembly 600 is pressed laterally into the lateralslot 614 in the wing, from either side. It is pressed inward until suchtime as the detent 608 engages the groove 618. The dimensions andconfigurations of the detent 608 and groove 618 are selected so as toreliably hold the target assembly in place during ordinary operatingconditions.

Lateral movement of the target assembly into and out of the wing isdesirable because there are relatively few forces applied to the wing orthe target assembly in that direction during normal operation.Consequently, such a configuration is less likely to result in thetarget assembly moving out of position under normal conditions for agiven retention configuration. The target assembly can also be insertedproximally from a distal point on the wing, from the tip end, or fromother directions, but such configurations may not be as desirable.

The retention feature for the target assembly, for example the detent608 and groove 618, can be placed at any number of locations relative tothe target assembly. For example, the detent 608 can be placed on anysurface of the target assembly, including the target element 602 and/orinsert 604, that will be adjacent or sufficiently close to acorresponding surface in the wing 124 to form a reliable retentionfunction. Additionally, the surface configurations described herein toachieve the retention function can be reversed relative to each otherand still achieve the same purpose. For example, the detent 608 can beformed on the distal wall 616 of the wing, and a complementary grooveformed in the insert 604, and still accomplish a retention function.Other configurations are also possible. Additionally, in some examples,it may be desirable to configure the lateral slot and the insert of thetarget assembly to minimize counter forces between the target assemblyand walls of the slot once the retention feature has been overcome, forexample by pushing the insert or otherwise releasing the retentionfeature.

In the examples of target assemblies described herein, the insert may beformed from silicone rubber, resilient urethane or the like having arelatively rigid configuration to withstand pressure, for example thatarising by pushing that would be used to place the insert in the lateralslot. Other biocompatible materials may also be used. The target elementwould be made from the same material as the other target elementsdescribed herein. In these configurations, the target assembly would bediscarded after the procedure. The remaining structures of the tissueclosure assembly can then be resterilized and reused, as is known tothose skilled in the art. For example, the closure assembly could beconstructed from stainless steel and be amenable to instrument cleaningmethods known in the art followed by either autoclave sterilization orethylene oxide sterilization modalities.

In another example of a retention feature (FIGS. 42-44), a targetassembly 630 includes a vertically extending detent 632 positioned neara lateral side surface of the target assembly. The detent 632 and itscomplementary surface in the wing 124B are otherwise formed insubstantially the same configuration as that described with respect toFIGS. 40-41. If the detent 632 is positioned at a trailing portion ofthe target assembly, any counter forces that might be developed throughfriction or other contact between the detent 632 and adjacent surfacesis nonexistent until such time as the target assembly is almost fully inplace. Conversely, the retention feature can be placed at a leadingportion of the target assembly, possibly also generating more counterforces.

In any examples of a target assembly, features can be included forminimizing the possibility of inadvertent or undesirable positioning ofthe target assembly in the wing. In some examples, keying structures canbe included to reduce or eliminate the possibility of undesirablepositioning of a target assembly in a wing. In one example of suchstructures shown in FIGS. 42-44, a ledge or wall structure 634 is formedon a proximal side surface of the target assembly 630, and extendslaterally along the wall. Additionally, a complementary, laterallyextending wall or groove 636 is formed in the proximal side surface ofthe slot 638 in the wing 124B. In the present example, the targetassembly would not be capable of significant insertion into the slot 638in the wing 124B in any orientation other than the proper one and onewhere the target assembly is rotated 180° about a proximal-distalextending axis, so that the ledge 634 still fits within the groove, butthe target assembly is upside down. In other orientations, the ledge 634would contact the distal wall surface and the detent 632 would contactthe proximal wall surface, and the target assembly would be relativelydifficult if not impossible to insert into the lateral slot. Otherkeying arrangements can be used besides or in addition to a ledge andgroove, as described in the present example.

Other keying or orientation configurations can be used either separatelyor in combination with other configurations to reduce the possibility ofinadvertent or undesirable positioning of the target assembly in thewing. In one example, for example as shown in FIGS. 42-44, the targetassembly is shaped so as to prevent or substantially inhibit orotherwise affect the progress of properly positioning the targetassembly in its corresponding wing. For example, where the targetassembly 630 includes a trapezoidal shape in top plan view, and the slotprofile has a shape that conforms, the target assembly may still bepositioned improperly in the slot with sufficient lateral force, but animproperly positioned target assembly will affect the progress ofpositioning in such a way that the user would notice a problem. In thepresent example, the shape and mentions of the target assembly 630 andthe corresponding shape and dimensions of the lateral slot 638 in thewing are such that the target assembly fits snugly in the lateral slotwhen properly positioned. In the present example, the trapezoidal shapeof the target assembly 630 is formed by angling the proximal and distalsurfaces out of square so that they are converging. Alternatively, oneof the sides can be angled and the other could be straight. It is alsonoted that this particular example shows an at least partly asymmetricalshape together with the ledge 634, the day or similar structures can beused separately if desired. They can also be used together as shown inthe example of FIGS. 42-44, or in combination with other features.

Other orientation configurations can include a stop wall that mightinhibit further forward progress if the target assembly was improperlyoriented, notches or walls or other complementary surfaces that wouldstop the target assembly when properly positioned and fully seated, aswell as other configurations.

Any of the examples of wing and target assembly configurations describedherein can include configurations facilitating removal of the targetassembly. In the example shown in FIGS. 42-43, a visual indicator aswell as a surface contributing to simple removal of the target assemblyis provided by a concave or arcuate surface 640. The concave surface 640serves as a depression surface for a thumb or finger to press againstthe target assembly to push it out or release it out of the lateralslot. Once the detent 632 is released from the corresponding groove inthe wing, in the example shown in FIGS. 42-44, the target assembly canbe removed and discarded at the end of a procedure. Additionally, if thetarget assembly also includes a shape such as the trapezoid shown inFIGS. 42, the target assembly is easier to remove once the detent isreleased because of the reduced drag between adjacent surfaces. Otherways to facilitate removal may include surface dimensions reducingfrictional engagement, and the like.

In another example, retention features and keying features can beincorporated into similar structures. In the example shown in FIGS.45-47, a target assembly 650 may include a plurality of retentionstructures such as detents 652 for engaging complementary structures inthe form of grooves 654 in the lateral slot 656 in the wings 124C. Inthis example, the target assembly 650 can be substantially square in topand bottom plan views, and substantially rectangular in a side elevationviews, but the pair of detents 652 will not retain adequately the targetassembly in place in the lateral slot unless the detents engage thegrooves 654. While it is still possible in the present example for thetarget assembly to be inserted upside down, and the target assembly canbe inserted laterally from either side of the wing, the pair of detentshelp to hold the target assembly in place when properly positioned, andmay also serve an orienting function.

A number of retention and keying or orienting functions can beincorporated into one assembly. As shown in FIGS. 48-50, a targetassembly 670 can include a plurality of detent features and a pluralityof orienting or keying features. In the present example, the targetassembly includes a plurality of detent structures 672. In the presentexample, the detents extend vertically, as viewed in FIG. 48, and arepositioned at trailing end portions of the target assembly. The detentsengage complementary grooves 674 formed in proximal and distal sidewalls of a lateral slot 676 in the wing 124D. Additionally, the targetassembly has proximal and distal side walls converging toward each otherso that, in plan view, the target assembly has a trapezoidal shaped.Likewise, the side profile of the slot 676 has a complementary shape.The target assembly also has a varying thickness from the leading-edgesurface 678 to the trailing edge surface 680, as illustrated in FIG. 50.Additionally, the profile of the lateral slot 676 has a complementaryshape. Consequently, there is only one proper orientation of the targetassembly in the corresponding wing 124D that will not have progressimpeded because of the shape or other orientation or keying function.

Any or all of the features of the removable or separable target assemblyembodiments depicted in or described with respect to FIGS. 40-50 can beincorporated into a monolithic target element formed from a singlematerial. For example, the assembly 600 (FIGS. 40-41) can be formed as amonolithic target element, for example with the material of the targetelement 602, and having a detent such as that described as the detent608 in FIGS. 40-41. Other than being formed monolithic and from thematerial the same as or similar to the material of the target element602, a monolithic target element can otherwise be the same orsubstantially the same as that described with respect to the assembly600 of FIGS. 40-41.

Alternatively or additionally, the assembly 630 (FIGS. 42-44) can beformed as a monolithic target element, for example with the material ofthe target elements described herein, and having one or more of a detentand/or a keying arrangement such as those described with respect to theassembly 630. Other than being formed monolithic and from the same orsimilar material to that of the target elements described herein, amonolithic target element can otherwise be the same or substantially thesame as that described with respect to the assembly 630 of FIGS. 42-44.

Alternatively or additionally, the assembly 650 (FIGS. 45-47) can beformed as a monolithic target element, for example with the material ofthe target elements described herein, and having one or more of thedetents and/or surface configurations as those described with respect tothe assembly 650. Other than being formed monolithic and from the sameor similar material to that of the target elements described herein, amonolithic target element can otherwise be the same or substantially thesame as that described with respect to the assembly 650 of FIGS. 45-47.

Alternatively or additionally, the assembly 670 (FIGS. 48-50) can beformed as a monolithic target element, for example with the material ofthe target elements described herein, and having one or more of thedetents and/or surface configurations as those described with respect tothe assembly 670. Other than being formed monolithic and from the sameor similar material to that of the target elements described herein, amonolithic target element can otherwise be the same or substantially thesame as that described with respect to the assembly 670 of FIGS. 48-50.

In other examples, which may be incorporated into any of the closureassemblies described herein, all or part of the movable part forming thewing can be separable into two or more components that can be releasablyjoined (for example through complimentary attachment elements), any oneor more of which components can be disposable and replaceable. In oneexample, the target assembly may form a substantial portion of the wing,such as wing 700 shown in FIGS. 51-58. It can be designed to be onemating component 702 to mate with another mating component 704 formingthe remaining portion of the wing 700, for example by coupling themtogether for use in the operation. In one example, a disposable orreplaceable wing portion 706 (FIGS. 52-53) may be configured to includea target element or target assembly (configured in the manner of any ofthose described herein) and be coupled or attached to the remaining orreusable wing portion 708 of the wing supported by the closure body.Upon assembly, the two wing portions combine to provide a continuousstructure that may be used according to the methods of use describedherein.

Various methods of mating the two components or coupling the wingportion holding the insert with the remaining portion of the closuredevice assembly are possible, and may include the attachment elementsdescribed with respect to the FIGS. 52-58 herein. In the example shownin FIGS. 52-53, a post 710 is provided on one or the other of the matingcomponents, in this example on the reusable wing 708, and a key feature712 is provided that projects orthogonally on the distal end of the post710 on the closure assembly. The disposable wing portion 706 featuringthe resilient rubber insert has a corresponding mating receptacle 714.This mating receptacle, at the proximal end of the replaceable wingcomponent 706 features a keyway complementary to the post 710 and key712 and that accepts the post and key from the opposite wing portion.When first joined, the two wing components are positioned at 90 degreesto each other, and when fully inserted, the wing portion holding theinsert may be rotated to a lock position within a complementary lockingslot in the disposable wing portion 706.

In another example, the coupling could be achieved as shown in FIGS.55-56. In this example, one or the other of a replaceable wing 720 and areusable wing 722 may include two cantilever projections 724 (in thisexample on the reusable wing 722) and the cantilever projections mayengage corresponding detents 726 projecting within acantilever-receiving opening 728 in the proximal end of the replaceablewing portion 720 holding or configured to hold the resilient rubberinsert. Insertion of the cantilever surfaces into the mating surfaces ofthe remaining wing portion of the closure assembly would provide lockingor coupling of the two portions as the cantilever projections coulddeflect inwardly during insertion and then return at least partly to thenon-deflected position upon full insertion (the non-deflectedconfiguration shown in FIG. 56). Upon this full insertion, the detents726 mate with corresponding grooves 730 on the cantilever elements 724of the reusable wing component.

Another example of reusable and disposable wing elements may be joinedby sliding components together, such as laterally. In one example shownin FIGS. 57-58, one or the other of a replaceable wing 740 and areusable wing 742 may include a continuous slot 744, in the presentexample in the replaceable wing component holding the rubber insert. Thecontinuous slot 744 has a keyway that accepts a mating feature or post746 with a key 748 on the other portion of the wing.

In the examples described with respect to FIGS. 52-58, the attachmentelements are post 710 and key feature 712, corresponding matingreceptacle 714, two cantilever projections 724 and corresponding detents726 in the cantilever-receiving opening 728, continuous slot 744, andpost 746 with the key 748.

For all of these embodiments above, upon completion of a procedure, thereplaceable wing portion holding the resilient insert could be unlocked,detached and discarded and the remaining wing portion and the overallclosure device assembly to which it is attached could be cleaned andresterilized.

In these embodiments of FIGS. 51-58, it is also contemplated that thewing portion attached to the closure assembly would articulate when theproximal handle of the device was manipulated as described in themethods of use described in this specification.

In these embodiments, the coupling mechanism features are reversible tothe extent that the features that enable mating coupling could be on thewing portion containing the insert and on the remaining wing portion asshown in FIGS. 51-58 or the features could be reversed so that the samemating and locking would be possible except the features described aboveare on the opposite wing component.

It should be understood that the inventions include any and all means toattach or couple or lock the mating surfaces of the device either withinor over each other. For example, the inventions would includeembodiments where the wing portion attached to the closure deviceassembly could include surfaces or features over which the targetassembly (i.e. wing portion that provides capture of the suture in themethods of use) could be mated and/or reversibly locked. For example,the target assemblies are described herein as being insertable andremovable from a cavity or slot in a wing. It should also be understoodthat a target assembly could be configured to be assembled onto a wingcomponent, such as by extending on or over a portion of a wingcomponent. For example, alternative to being inserted in a cavity orslot in the wing, a wing component can include a skeleton or othersupporting frame that would be one mating component that a targetassembly as a second mating component can be mounted onto or attached tofor support and movement with the wing. In another example, a targetassembly as one mating component can be clipped onto a wing component asthe other mating component, or embedded or otherwise joined on the wingcomponent.

All removable or separable target assembly embodiments depicted in ordescribed with respect to FIGS. 40-58 are amenable to kitting whereinthe disposable elements could be provided to the user separate from theremaining structures of the tissue closure assembly. For example, in oneembodiment two removable target assemblies could be provided in asterile pack ready for loading into a resterilized, reusable trocarclosure assembly. A kit could alternatively contain one assembly or morethan two, as desired. In one embodiment, it is envisioned that one ormore suture needles to be used with such a tissue closure assembly couldalso be included in the sterile kit with the disposable, targetassemblies. Alternatively, the suture needle could be constructed ofsturdier materials to withstand reuse and resterilization and thuspotentially eliminated from such a kit as well.

One or more of the presently-described apparatus can be used for closingtissue openings using methods described herein, and other apparatus canbe used with one or more of these methods as well. In one process, atissue opening (for example, one formed by a trocar) can be closed byremoving the trocar and introducing a closure device into the opening.In a first example, the closure device is not preloaded with anysutures, and in a second example the closure device is preloaded withone or more sutures.

In the first example, a closure device such as that of 102 illustratedin FIGS. 1-12 is placed in the insertion configuration, shown in FIG.12. The actuator sleeve is placed at a distal position (FIG. 12) and thelocking pin of the lock 156 inserted into the distal opening 162 on theclosure body (FIG. 16). The wings 124 extend axially of the body andhave their respective flat faces facing each other. The closure device102 is then inserted into the trocar opening 106 until the upper skinlayer approaches the proximal indicator 194. If the opening is undervisualization, the closure device can be inserted until the distalindicator 198 passes beyond the peritoneal layer 114. Once it is decidedthat the closure device is inserted sufficiently for deployment of thewings 124, the locking element 156 is withdrawn from the second opening162 and the actuator sleeve moved proximally until the locking pin canbe engaged with the proximal opening 160. As the actuator sleevetranslates proximally, the pull rod 130 translates axially in theproximal direction within its rectangular shaft in the body. The pullrod 130 pulls the link arms 132 upward causing wings 124 to pivot aboutretaining pins through the mounting structure 126 at the distal end ofthe body. When the locking element 156 engages the proximal opening 160the wings 124 are fully deployed substantially laterally andperpendicular to the central axis of the body and to the pull rod 130.The upper surfaces 140 of the wings are substantially adjacent theperitoneal layer and the target access openings 138 are aligned withtheir respective passageways in the body 116.

The needle assembly 104 has been previously loaded with an adequatelength of suture 336 by placing a bight of an end portion of the sutureon the shaft 312 proximal of the protrusion 332 (FIG. 31). While thesuture contacts the side of the needle, the suture is moved distallyalong the converging surface toward the tip 332 and down into theopening 320. The suture 336 is then moved proximally along the rampsurface 324 and under the protrusion 326 and moved against the grooverestriction by application of an increased force until the suture 336seats in the bottom of the groove. The holding of the suture can betested by releasing the suture and letting it hang from the groove. Thesuture-carrying needle can then be introduced into the opening 170 inthe closure device as represented in FIGS. 1-5.

The operator grasps the closure device at the grasping surfaces 182 andlifts the closure device against the peritoneal layer and separates thetissue layers further away from the underlying organs or other tissuesin the abdominal insufflated cavity. With the operator's fingersunderneath the shield or guard 186, the needle assembly is inserted intothe opening 170 and advanced along the passageway 172 with the needleindicator 338 on the handle oriented as shown in FIGS. 1-5. As theneedle tip exits the exit opening 178, the needle tip penetrates thetissue surrounding the trocar opening in the area above the fasciallayer 112. As the needle shaft continues along the passageway and theneedle tip penetrates further into the tissue, the needle tip approachesthe target access opening 138, all the while carrying the loaded sutureend portion.

The needle point punctures the proximal facing surface of the targetelement 136 and continues through the target element until the base 316of the needle handle bottoms out against the guard 186 or the conicalopening 170, as predetermined by the relative sizes and positions of theguard and the handle. If operating under scope-based visualization,suitable embedding of the suture in the target element can be confirmed.The needle assembly can then be withdrawn from the target element, withthe frictional engagement between the silicone rubber of the targetelement and the suture acting to hold the suture embedded in the targetelement as the needle is withdrawn. The needle assembly is fullywithdrawn from the closure device and reloaded with the other end of thesuture or another suture (or another needle assembly can be used). Whilethe operator grasps the closure device about the grasping surfaces 182and lifts the device, the suture-loaded needle assembly 104 isintroduced to the second opening 176 and along the second passageway 174to embed the suture in the target element of the diametrically oppositewing 124 (see phantom needle in FIG. 2). The needle assembly is thenwithdrawn again. With closure devices having more wings and passageways,the process (procedural steps described above) can be repeated for eachone.

The locking element 156 is then released and the spring bias moves theactuating sleeve distally, closing the wings 124 until the lockingbutton 156 engages the second opening 162 and locks in place. Theclosure device holding the embedded suture ends in each wing can then beremoved from the trocar opening, also drawing suture into the tissue andout through the trocar opening. The suture lengths residing in thepassageways can be removed out of the slots 180 either before or afterthe closure device is removed from the trocar opening. The embeddedsutures can also be manually removed from the silicone rubber targetelements in the wings. The sutures can then be tied off as desired tocomplete the closure.

In the second example process, one or more sutures are first anchored onrespective wings of a closure device and then subsequently introducedinto a tissue opening, for example a trocar opening. With a pair ofwings, a single length of suture can have its ends anchored inrespective wings with the connecting loop remaining outside the trocaropening. The suture ends can be anchored on the wings for example bybeing embedded in a relatively high friction material such as siliconerubber, or by engaging one or more structures on or about the wings suchas by interference fit or frictional engagement, by wrapping, by a cleatarrangement, by a miniaturized clamp or by various other active orpassive means. In one configuration, a suture end portion is anchored byspaced apart anchor elements on each side of the wing and with theintermediate suture length extending over an open area forming thetarget area for a grasping or retrieving element. The grasping orretrieving element will then approach the target area, for example withjaws or other grasping mechanisms open to engage the suspended sutureportion. The sutures can be left outside the body of the closure device.

The closure device with the sutures mounted and in the insertionconfiguration is then inserted into the trocar opening until theindicators show that the closure device is sufficiently inserted. Thewings are then deployed, and the closure device positioned within thetrocar opening to form a gap between the wings and the peritoneal layer.While the operator grasps the closure device at the grasping surfaces182, a retrieval tool is introduced into the opening 170 and along thepassageway 172. The retrieval tool is sufficiently sharp to pierce thetissue layers in order to reach the embedded suture on the associatedwing. The retrieval tool may include jaws or other grasping elements forsecurely holding the suture. Alternatively, the retrieval tool canutilize a groove which enables the operator to let the suture ‘run’instead of being grasped when withdrawn as commonly done in orthopedicapplications involving sutures. This method would include loading themidsection of the suture, providing an adequate length of suture on therespective anchor elements before insertion of the device. In eitherembodiment, as the working portion of the retrieval tool exits theperitoneal layer, the working portion is activated, for example byopening jaws, and the tool is advanced to retrieve the midsection of thesuture mounted in the anchor element. Once the tool is fully advanced inthe passageway, such as up to a stop point, the jaws or other workingportion are closed and the suture is either allowed to run or is graspedand withdrawn until it exits the tissue layers and the passageway, andthen released once a suture end is visible. The retrieval tool is theninserted into the other passageway to retrieve the other suture elementin like manner. These procedural steps can be repeated if multiple wingsare used. It is also noted that other mechanical means can be used toretrieve the suture.

When each of the suture end portions have been retrieved and released,the closure device can be reset to the insertion configuration andremoved from the trocar opening. Because the sutures are free of theclosure device, suture escape slots are neither used nor necessary toremove suture elements from the passageways. Traction draws the freeends of the suture tight with the intermediate loop portion against theopening and the suture ends are then tied off to effect a full thicknessclosure of the fascial layer.

With a closure device where the suture is anchored on the wings beforethe closure device is inserted into the trocar opening, the closuredevice may be configured to have a longer body to provide the gapbetween the peritoneal layer and the target wings, to therebyaccommodate the working portions of the retrieval tool. In thisconfiguration, the distal marker 198 is moved proximally to the distalend of the taper 190. The length of the body, for example the taper, isincreased a like amount so that the distal indicator 198 stillsubstantially aligns with the peritoneal layer. Additionally, becausethe trajectory of the retrieval tool is still determined by the centralaxis of the passageway 172, which has now shifted axially upward awayfrom the target wings, the target access opening or the target area forthe retrieval tool is shifted radially outward from the closure bodybeyond 1 cm (assuming the angle of inclination of the passageway isunchanged). The actual increase in the distance 202 (FIG. 2) can becalculated as a function of the increase in body length of the closuredevice.

The closure devices can be formed from a number of bio-compatiblematerials, such as polycarbonate, and the various metal parts may beformed from suitable medical grade materials including stainless steel.The needle handle may also be formed, machined, cast or molded from asuitable bio-compatible material. The needle shaft and tip may be formedfrom a hardened stainless steel or similar material. In some examples,though other dimensions may be used as well, a standard length closuredevice would have an outside diameter of approximately 12 mm and a 2.5inch working length, with the passageway exit holes about 2.5 cm abovethe peritoneum and with the wings producing a lateral bite of about 1cm. An extra-length device for example may have a 3.5″ working lengthand the exit holes would be about 3 cm from the peritoneum and with thewings provide a lateral bite of about 1 cm. The needle on the needleassembly may have an approximately 10 cm minimum working length with amaximum 2 mm outside diameter.

Having thus described several exemplary implementations, it will beapparent that various alterations and modifications can be made withoutdeparting from the concepts discussed herein. Such alterations andmodifications, though not expressly described above, are nonethelessintended and implied to be within the spirit and scope of theinventions. Accordingly, the foregoing description is intended to beillustrative only.

What is claimed is:
 1. A device for use in suturing tissue, the devicecomprising: a closure body extending from a proximal portion to a distalportion and defining a central axis, the proximal portion for beingpositioned on a first side of tissue and the distal portion for beingpositioned on a second side of tissue, wherein at least one of theproximal and distal portions of the device includes a first structuredefining a first mating component and a second mating component for thefirst mating component such that the first mating component and thesecond mating component are rotatable together relative to the centralaxis, wherein at least one of the first mating component and secondmating component is configured to receive a suture, wherein the firstmating component includes a slot extending from a proximal side surfaceof the first mating component, and wherein the second mating componentis configured for insertion into the slot, the second mating componentincluding at least one detent structure for engaging a complementarygroove of the first mating component.
 2. The device of claim 1, whereinthe second mating component includes first and second separable elementsmade from materials having different hardnesses.
 3. The device of claim2, wherein the first element of the second mating component isconfigured to be removably retained in the slot of the first matingcomponent and the second element supported by the first element.
 4. Thedevice of claim 3, wherein the first element is a housing and the secondelement is a suture-receiving pad.
 5. The device of claim 1, wherein thefirst structure on the first mating component is a movable element andwherein the second mating component is removably attachable to themovable element.
 6. The device of claim 1, wherein the first matingcomponent forms part of a wing and wherein the second mating componentforms another part of the wing, and wherein combining the first andsecond mating component allows them to move together.
 7. The device ofclaim 6, wherein the second mating component includes a portion formedof a resiliently flexible material.
 8. The device of claim 1, whereinthe at least one detent structure is disposed on a trailing edge surfaceof the second mating component relative to an insertion direction of thesecond mating component into the first mating component.
 9. The deviceof claim 1, wherein the slot of the first mating component furtherdefines a laterally extending groove, and wherein the second matingcomponent includes a ledge that is configured to fit in the laterallyextending groove when the second mating is inserted into the firstmating component.
 10. The device of claim 1, wherein first matingcomponent includes a concave or arcuate surface, opposite of theproximal side surface of the first mating component, to serve as adepression surface to allow the second mating component to be pushed outor released out of the slot of the first mating component.
 11. Aremovable suture target assembly for a device for suturing tissue, theassembly comprising: a housing having at least first and second surfacesasymmetric with respect to each other about at least one of threemutually perpendicular axes of the housing, wherein at least one of theaxes extends normal to at least one of the surfaces of the housing, anda resiliently flexible material supported by the housing for receivingand then holding a suture from a suture-carrying needle, and wherein theresilient flexible material includes an unperforated proximal surfaceconfigured to receive and embed the suture in the resilient flexiblematerial after being punctured by the suture-carrying needle.
 12. Theassembly of claim 11, wherein a cross-section through the first andsecond surfaces defines a substantially trapezoidal shape.
 13. Theassembly of claim 12, wherein the cross-section is a first cross-sectionand further including a second cross-section perpendicular to the firstcross-section through the first and second surfaces and wherein thesecond cross-section defines a substantially trapezoidal shape.
 14. Theassembly of claim 11, wherein the first surface is substantially flat,and wherein the second surface is non-flat.
 15. The assembly of claim11, further including an attachment element for attachment to a tissueclosure device.
 16. The assembly of claim 15, wherein the attachmentelement includes a detent.
 17. The assembly of claim 11, wherein theassembly is configured to be insertable into a slot or cavity of asuture-receiving element.
 18. The assembly of claim 11, wherein theassembly extends along a central axis from a first end portion to asecond end portion, and wherein the first end portion includes anattachment element for removable attachment to a suturing device. 19.The assembly of claim 18, wherein the resiliently flexible materialincludes a portion positioned between the first and second end portions.20. A removable suture target assembly for a device for suturing tissue,the assembly comprising: a housing having at least a first attachmentelement for attachment to a tissue closure device, and a resilientlyflexible material supported by the housing, wherein the housing includesa mating receptacle for attaching to the device for suturing, the matingreceptacle having a keyway feature for receiving a post with anorthogonally extending key, and for locking to the post by rotation ofthe housing relative to the post and the key, and wherein the resilientflexible material includes an unperforated proximal surface configuredto receive and embed a suture carried by a suture-carrying needle in theresilient flexible material after being punctured by the suture-carryingneedle.